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NCT00452790 Clinical Trial

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Pneumococcal Infections Clinical Trial

Official title:
A Phase 3, Randomised, 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 India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452790
Other study ID # 6096A1-011
Secondary ID
Status Completed
Phase Phase 3
First received March 23, 2007
Last updated March 22, 2011
Start date June 2007
Est. completion date February 2010

Study information
Verified date March 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority India: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 708
Est. completion date February 2010
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 42 Days to 72 Days
Eligibility Inclusion Criteria

1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment

2. Available for the entire study period

Exclusion Criteria

1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines

2. A previous anaphylactic reaction to any vaccine or vaccine-related component

3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
• 7 valent pneumococcal conjugate vaccine
1 dose at 6, 10, 14 weeks and 12 months of age

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (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 19 A) are presented. 1 month after the infant series (18 weeks of age) No
Primary Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented. 1 month after the infant series (18 weeks of age) No
Secondary Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose. Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 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 19 A) are presented. 1 month after the toddler dose (13 months of age) No
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