Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

Pneumococcal Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452452
• Other study ID #: 6096A1-3002
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2007
• Last updated: July 6, 2012
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: 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) in older infants and children who have not previously been immunized with Pneumococcal vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Months to 5 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine

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

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Antibody Level =0.35µg/mL After Vaccination	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold =0.35µg/mL along with the corresponding 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 19A) are presented.	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).	No
Primary	Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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 19A) are presented.	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).	No
Secondary	Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Secondary	Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever = 37.5 degrees Celsius [C], fever = 38 C but = 39 C, fever >39 C but = 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes