Clinical trial NCT00452790: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Vaccines, Pneumococcal
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 708
Sex: ALL
Minimum age (years): 42
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 month after the infant series (18 weeks of age)
measure: 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.
timeFrame: 1 month after the infant series (18 weeks of age)
Secondary outcomes:
measure: Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
timeFrame: 1 month after the toddler dose (13 months of age)
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
timeFrame: 1 month after the 3-dose infant series (18 weeks of age)
measure: GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
timeFrame: 1 month after toddler dose (13 months of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
timeFrame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
timeFrame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
timeFrame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after the toddler dose (12 months of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
timeFrame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
timeFrame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
timeFrame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after the toddler dose(12 months of age)
Locations:
city: Sector-12
country: India
state: Chandigarh
city: Sector-32 B
country: India
state: Chandigarh
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Mumbai
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Rajinder Nagar
country: India
state: New Delhi
city: Ludhiana
country: India
state: Punjab
city: Chennai
country: India
state: Tamil Nadu
city: Vellore
country: India
state: Tamil Nadu
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: