Clinical trial NCT00205803: Study Evaluating Pneumococcal Vaccine in Healthy Infants
Official title: A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Subjects
Pneumococcal Infections
Keywords: Infant Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 249
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.


Eligibility criteria: Inclusion Criteria:

1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
2. In good health as determined by medical history, physical examination and judgment of the investigator,
3. Subject must have been born ≥36 weeks of gestational age,
4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine,
2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
4. 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. Does not include resolving syndromes due to birth trauma such as Erb palsy,
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
6. History of culture-proven invasive disease caused by S. pneumoniae,
7. Previous anaphylactic reaction to any vaccine or vaccine components,
8. Major known congenital malformation or serious chronic disorders,
9. Participation in another investigational study (however, observation-only trials are permitted),
10. Known or suspected immune deficiency/suppression,
11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).

Primary outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions
timeFrame: Within 15 days after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events
timeFrame: Within 15 days after each dose
measure: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: one month after 3-dose infant series (at 7 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: One month after the toddler dose (at 13 to 16 months of age)
measure: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: One month after 3-dose infant series (at 7 months of age)
measure: Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
timeFrame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)
measure: Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: One month after the infant series (7 months of age)
measure: Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: one month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: One month after the toddler dose (13 to 16 months of age)
measure: Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: One month after the Toddler Dose (13 to 16 months of age)
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.