Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00366678
• Date of registration: 17/08/2006
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
• Scientific 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 Pediatric Vaccinations in France.
• Date of first enrolment: October 2006
• Target sample size: 613
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00366678
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Trial Manager
• Affiliation: For France, [e-mail]

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy 2-month-old infants.

- Available for the entire study period.

Exclusion criteria:

· Known contraindication to vaccines.



Age minimum: 42 Days
Age maximum: 98 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal

Intervention(s)

Biological: 7-valent pneumococcal conjugate vaccine

Drug: Pentavac

Biological: 13-valent pneumococcal conjugate vaccine

Primary Outcome(s)

Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]

Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age)]

Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]

Percentage of Participants Achieving a Pneumococcal Antibody Level =0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age)]

Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group [Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]

Percentage of Participants Reporting Pre-Specified Local Reactions [Time Frame: During the 4-day period after each dose]

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [Time Frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]

Percentage of Participants Reporting Pre-Specified Systemic Events [Time Frame: During the 4-day period after each dose]

Secondary Outcome(s)

Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [Time Frame: One month after the Toddler Dose (at 13 months of age)]

Percentage of Participants Achieving a Pneumococcal Antibody Level =0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [Time Frame: One month after the toddler dose (at 13 months of age)]

Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose [Time Frame: One month after the toddler dose (at 13 months of age)]

Percentage of Participants Achieving Antibody Titer =1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups [Time Frame: One month after the toddler dose (at 13 months of age)]

Secondary ID(s)

6096A1-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00366678