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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 - Catch-up study

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 - Catch-up study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006779-19-PL
Enrollment
354
Registered
2007-03-29
Start date
2007-06-06
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy infants and children

Interventions

Product Name: 13vPnC Product Code: 6096A1 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Pneumococcal polysaccharide serotype 1 Concentration unit: µg/ml microgram(s)/millilitre Co

Sponsors

Wyeth Research Division of Wyeth Pharmaceuticals Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged from 7 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 vaccines. 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary Objective: - To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after last scheduled dose of 13vPnC in each age group.;Secondary Objective: Safety Objective: - To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).;Primary end point(s): The primary endpoint for each of the pneumococcal serotypes is the proportion of subjects achieving a serotype specific IgG antibody concentration =0.35 µg/mL measured 1 month after the last scheduled dose of 13vPnC. This choice of endpoints is based upon a World Health Organization (WHO) guideline for the pneumococcal serotypes.—

Countries

Poland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026