Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

• ClinicalTrials.gov Identifier: NCT01939158
• Recruitment Status: Completed
• First Posted: September 11, 2013
• Results First Posted: October 5, 2021
• Last Update Posted: October 5, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

Condition or disease	Intervention/treatment	Phase
Infections, Meningococcal	Biological: Meningococcal vaccine GSK134612; Biological: Prevenar 13™	Phase 3

Detailed Description:

The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 803 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES
• Actual Study Start Date: October 2, 2013
• Actual Primary Completion Date: December 5, 2019
• Actual Study Completion Date: December 5, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACWY1d group; Subjects will receive 1 dose of the MenACWY-TT vaccine	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
Experimental: ACWY2d group; Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
Experimental: Co-ad group; Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region; Biological: Prevenar 13™; 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
Active Comparator: PCV-13 group; Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region; Biological: Prevenar 13™; 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
2. Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group [ Time Frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
3. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 1 ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
4. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 1 ]
   Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
5. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 3 ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
6. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 3 ]
   Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
7. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 5 ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
8. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 5 ]
   Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
9. Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups [ Time Frame: 1 month after administration of Prevnar 13 (i.e. at Month 1) ]
   GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.

Secondary Outcome Measures :

1. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
2. Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group [ Time Frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
3. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) ]
   Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
4. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group [ Time Frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) ]
   Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
5. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
6. Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) ]
   Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
7. Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
8. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups [ Time Frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) ]
   Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
9. Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 1, Year 3, Year 5 ]
   Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
10. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups [ Time Frame: At Year 1, Year 3, Year 5 ]
    Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
11. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups [ Time Frame: At Year 1, Year 3, Year 5 ]
    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
12. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups [ Time Frame: At Year 1, Year 3, Year 5 ]
    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
13. Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups [ Time Frame: 1 month after administration of Prevnar 13 (i.e. at Month 1) ]
    Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
14. Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups [ Time Frame: 1 month after administration of Prevnar 13 (i.e. at Month 1) ]
    OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
15. Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups [ Time Frame: 1 month after administration of Prevnar 13 (i.e. at Month 1) ]
    OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.
16. Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination [ Time Frame: Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2]) ]
    Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category.
17. Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination [ Time Frame: Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2]) ]
    Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively.
18. Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: Within 31 days post any vaccination ]
    An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.
19. Number of Participants With Serious Adverse Events From Month 0 to Month 9 [ Time Frame: Month 0 to Month 9 ]
    An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
20. Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study [ Time Frame: Baseline up to end of study (up to 5 years) ]
    An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.
21. Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9 [ Time Frame: Month 0 to Month 9 ]
    New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 14 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.

Exclusion Criteria:

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Previous vaccination against Neisseria meningitidis.
• Previous booster vaccination against Streptococcus pneumoniae.
• Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
• History of meningococcal disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*

  • Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
• Acute disease and/or fever at the time of enrollment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Contacts and Locations

Locations

Australia, Australian Capital Territory

Canberra Hospital

Garran, Australian Capital Territory, Australia, 2605

Australia, New South Wales

The Childrens Hospital at Westmead

Westmead, New South Wales, Australia, 2145

Australia, South Australia

Women's and Children's Hospital

North Adelaide, South Australia, Australia, 5006

Australia, Victoria

Vaccine and Immunization Research Group

Melbourne, Victoria, Australia, 3010

Australia, Western Australia

Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital

Nedlands, Western Australia, Australia, 6009

Canada, Manitoba

The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM]

Winnipeg, Manitoba, Canada, R3E 3P4

Canada, Nova Scotia

Canadian Center for Vaccinology - IWK Health Centre

Halifax, Nova Scotia, Canada, B3K 6R8

Canada, Ontario

Dr. Allen Greenspoon Medicine Professional Corporation

Hamilton, Ontario, Canada, L8L 5G8

Medicor Research Inc.

Sudbury, Ontario, Canada, P3A 1W8

Canada, Quebec

CHU de Quebec-Universite Laval

Quebec City, Quebec, Canada, G1E 7G9

Czechia

Medicentrum 6 s.r.o

Praha 6, Vokovice, Czechia, 160 00

Ordinace praktickeho lekare pro deti a dorost

Benesov, Czechia, 256 01

Ordinace praktickeho lekare pro deti a dorost

Boletice nad Labem, Czechia, 40711

Ordinace praktickeho lekare pro deti a dorost

Brandys nad Labem, Czechia, 250 01

Ordinace praktickeho lekare pro deti a dorost

Caslav, Czechia, 286 01

Ordinace praktickeho lekare pro deti a dorost

Chrastava, Czechia, 463 31

Ordinace praktickeho lekare pro deti a dorost

Chrudim 2, Czechia, 537 01

Krajska zdravotni, a.s., Nemocnice Decin

Decin, Czechia, 405 01

Ordinace praktickeho lekare pro deti a dorost

Domazlice, Czechia, 34401

Ordinace praktickeho lekare pro deti a dorost

Holice, Czechia, 534 01

Ordinace praktickeho lekare pro deti a dorost

Hradec Kralove, Czechia, 500 02

Ordinace praktickeho lekare pro deti a dorost

Hradek nad Nisou, Czechia, 463 34

Ordinace praktickeho lekare pro deti a dorost

Hronov, Czechia, 54931

Ordinace praktickeho lekare pro deti a dorost

Jindrichuv Hradec, Czechia, 377 01

Ordinace Praktickeho Lekare Pro Deti A Dorost

Kladno, Czechia, 272 01

Ordinace praktickeho lekare pro deti a dorost

Krupka, Czechia, 417 41

Ordinace praktickeho lekare pro deti a dorost

Liberec 7, Czechia, 460 07

Ordinace praktickeho lekare pro deti a dorost

Melnik, Czechia, 276 01

Oblastni nemocnice Nachod

Nachod, Czechia, 547 01

Ordinace praktickeho lekare pro deti a dorost

Neveklov, Czechia, 257 56

Ordinace praktickeho lekare pro deti a dorost

Novy Jicin, Czechia, 741 01

Ordinace Praktickeho Lekare pro deti a dorost

Odolena Voda, Czechia, 250 70

Ordinace praktickeho lekare pro deti a dorost

Ostrov Nad Ohri, Czechia, 36301

Ordinace praktickeho lekare pro deti a dorost

Ostrov, Czechia, 363 01

Ordinace praktickeho lekare pro deti a dorost

Pardubice, Czechia, 530 03

Ordinace praktickeho lekare pro deti a dorost

Pardubice, Czechia, 530 09

Ordinace praktickeho lekare pro deti a dorost

Pardubice, Czechia, 530 12

Nemocnice Pardubice

Pardubice, Czechia, 532 03

Ordinace praktickeho lekare pro deti a dorost

Praha 3, Czechia, 130 00

Ordinace praktickeho lekare pro deti a dorost

Praha 5, Czechia, 15200

Ordinace praktickeho lekare pro deti a dorost

Smirice, Czechia, 503 03

Ordinace Praktickeho Lekare pro deti a dorost

Trutnov, Czechia, 541 01

Ordinace praktickeho lekare pro deti a dorost

Tynec nad Sazavou, Czechia, 257 41

Panama

Centro Pediatrico America, Consultorios America

Panama, Panama

CEVAXIN Plaza Carolina

Panama, Panama

Consultorios America Via Espana

Panama, Panama

ULAPS Guadalupe

Panama, Panama

South Africa

Chris Hani Baragwanath Academic Hospital

Soweto, Gauteng, South Africa, 2013

Setshaba Clinical Research

Gauteng, South Africa, 0152

Turkey

Hacettepe University Faculty of Medicine

Ankara, Sihhiye, Turkey, 06100

Ege University Hospital Medical Faculty

Izmir, Turkey, 35100

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] May 9, 2018

Statistical Analysis Plan  [PDF] November 11, 2016

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01939158
• Other Study ID Numbers: MENACWY-TT-104; C0921003 ( Other Identifier: Alias Study Number ); 2013-001083-28 ( EudraCT Number ); 116892 ( Other Identifier: Alias Study Number )
• First Posted: September 11, 2013
• Results First Posted: October 5, 2021
• Last Update Posted: October 5, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Pfizer:

Co-administration; Safety; Persistence; Immunogenicity; Prevenar 13; Meningococcal vaccine; Toddlers; 5 years

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs