Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00366899
First received: August 17, 2006
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.


Condition Intervention Phase
Vaccines, Pneumococcal
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7 valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.

  • Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose [ Time Frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.

  • Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose [ Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)

  • Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose [ Time Frame: One month after the infant series (6 months of age) and the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.

  • Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose [ Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).

  • Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose [ Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).

  • Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose [ Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    GMC of Polio as measured using a polio in vitro plaque neutralization.

  • Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose [ Time Frame: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age) ] [ Designated as safety issue: No ]
    Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose [ Time Frame: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age) ] [ Designated as safety issue: No ]
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.


Secondary Outcome Measures:
  • Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.


Other Outcome Measures:
  • Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose [ Time Frame: one month after infant series dose 2 and after the toddler dose ] [ Designated as safety issue: No ]
    Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).

  • Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose [ Time Frame: one month after infant series dose 2 and after the toddler dose ] [ Designated as safety issue: No ]
    Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.


Enrollment: 605
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13-valent pneumococcal conjugate vaccine
Biological: 13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
Active Comparator: 2
7-valent pneumococcal conjugate vaccine
Biological: 7 valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.

  Eligibility

Ages Eligible for Study:   75 Days to 105 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Aged 3 months (75 to 105 days) at time of enrollment.
  2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
  5. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae or Hib.
  8. Major known congenital malformation or serious chronic disorder.
  9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® [MedImmune]).
  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366899

Locations
Italy
Napoli, Campania, Italy, 80122
Napoli, Campania, Italy, 80139
Bologna, Emilia Romagna, Italy, 40138
Roma, Lazio, Italy, 00165
Roma, Lazio, Italy, 00100
Genova, Liguria, Italy, 16132
Milan, Lombardia, Italy, 20122
Novara, Piemonte, Italy, 28100
Taranto, Puglia, Italy, 74100
Sassari, Sardegna, Italy, 07100
Ragusa, Sicilia, Italy, 97100
Palermo, Sicillia, Italy, 90100
Firenze, Toscana, Italy, 50132
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00366899     History of Changes
Other Study ID Numbers: 6096A1-500
Study First Received: August 17, 2006
Results First Received: March 26, 2010
Last Updated: January 17, 2013
Health Authority: Italy: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaccine
Infants

ClinicalTrials.gov processed this record on October 21, 2014