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Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

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ClinicalTrials.gov Identifier: NCT01641133
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : February 27, 2017
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Condition or disease Intervention/treatment Phase
Infections, Streptococcal Biological: Synflorix (3-Dose) Biological: Synflorix (2-Dose) Biological: Synflorix (Single Dose) Biological: Prevenar 13 (Single Dose) Biological: Prevenar 13 (2-Dose) Phase 3

Detailed Description:
This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™
Actual Study Start Date : September 4, 2012
Actual Primary Completion Date : July 15, 2013
Actual Study Completion Date : May 7, 2014


Arm Intervention/treatment
Active Comparator: Synflorix Group
Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Biological: Synflorix (3-Dose)
3 doses administered intramuscularly

Experimental: Prevnar 1 Group
Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
Biological: Synflorix (2-Dose)
2 doses administered intramuscularly

Biological: Prevenar 13 (Single Dose)
1 dose administered intramuscularly

Experimental: Prevnar 2 Group
Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Biological: Synflorix (Single Dose)
1 dose administered intramuscularly

Biological: Prevenar 13 (2-Dose)
2 doses administered intramuscularly




Primary Outcome Measures :
  1. Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period [ Time Frame: Within 31-day (Day 0-Day 30) after any dose of primary vaccination ]
    The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.


Secondary Outcome Measures :
  1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose ]
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  2. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period [ Time Frame: During the 4-day (Days 0-3) post-booster vaccination period ]
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  3. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose ]
    Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

  4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period [ Time Frame: During the 4-day (Days 0-3) post-booster vaccination period ]
    Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

  5. Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination period ]
    The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.

  6. Number of Subjects With Unsolicited AEs - Primary Period [ Time Frame: During the 31-day (Days 0-30) post-primary vaccination period ]
    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  7. Number of Subjects With Unsolicited AEs - Booster Period [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination period ]
    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  8. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From first vaccination (Month 0) up to study end (11-14 months) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  9. Antibody Concentrations Against Pneumococcal Serotypes [ Time Frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination) ]
    Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

  10. Concentrations of Antibodies Against Protein D (Anti-PD) [ Time Frame: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination) ]
    Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.

  11. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes [ Time Frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination) ]
    The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
  • 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 product.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any seizures or progressive neurological disease.
  • Administration of immunoglobulins and/or blood products since birth or planned use during the study.
  • Acute disease and/or fever at the time of enrolment.
  • Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641133


Locations
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Mexico
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62210
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
GSK Investigational Site
Mexico, Mexico, 04530
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641133     History of Changes
Other Study ID Numbers: 115992
2013-003479-36 ( EudraCT Number )
First Posted: July 16, 2012    Key Record Dates
Results First Posted: February 27, 2017
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study in a publication manuscript.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
URL: http://clinicalstudydatarequest.com
Keywords provided by GlaxoSmithKline:
pneumococcal conjugate vaccine
Synflorix
Prevnar 13
Pneumococcal diseases
Additional relevant MeSH terms:
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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs