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Completed

NCT Number: NCT00452452

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

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

7 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bydgoszcz, Poland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

Primary outcomes

  1. Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination

    Time frame: 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).

    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.

  2. Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups

    Time frame: 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).

    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.

Secondary outcomes

  1. Percentage of Participants Reporting Pre-Specified Local Reactions

    Time frame: During the 4-day period after each dose

    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.

  2. Percentage of Participants Reporting Pre-Specified Systemic Events

    Time frame: During the 4-day period after each dose

    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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2007
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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