Clinical trial NCT00452452: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Official title: A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Vaccines
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 355
Sex: ALL
Minimum age (years): 7
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_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) in older infants and children who have not previously been immunized with Pneumococcal vaccine.


Eligibility criteria: Inclusion Criteria:

1. Aged from 7 months to \<72 months at time of enrollment.
2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. 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.
9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.

Primary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
timeFrame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
measure: Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
timeFrame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Secondary outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions
timeFrame: During the 4-day period after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events
timeFrame: During the 4-day period after each dose
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
city: Bydgoszcz
country: Poland
city: Debica
country: Poland
city: Krakow
country: Poland
city: Leczna
country: Poland
city: Lodz
country: Poland
city: Oborniki Salskie
country: Poland
city: Proznan
country: Poland
city: Trzebnica
country: Poland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Poland: WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: