Skip to main content
OpenTrials
Completed

NCT Number: NCT00688870

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaccines Pneumococcal Conjugate Vaccine

Age range

42 day–98 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy 2-month-old infants (42 to 98 days)
  • Available for the entire study period (14 months)

Exclusion criteria

  • Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.

Treatment and study plan

13-valent pneumococcal conjugate vaccine (13vPnC)

Biological

13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

7-valent pneumococcal conjugate vaccine (7vPnC)

Biological

7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Primary outcomes

  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.

    Time frame: 1 month after the infant series (7 months of age)

    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (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.

Secondary outcomes

  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose

    Time frame: 1 month after toddler dose (16 months of age)

    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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.

Other outcomes

  1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series

    Time frame: 1 month after the 3-dose infant series (7 months of age)

    Antibody GMC as measured in mcg/mL 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.

  2. GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose

    Time frame: 1 month after the toddler dose (16 months of age)

    Antibody GMC as measured in mcg/mL 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.

  3. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).

    Time frame: Within 4 days after Dose 1 of the infant series (2 Months of Age)

    Local reactions were reported 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 and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

  4. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

    Time frame: Within 4 Days after Dose 2 of the infant series (4 months of age)

    Local reactions were reported 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 and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

  5. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

    Time frame: Within 4 days after Dose 3 of the infant series (6 months of age)

    Local reactions were reported 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 and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

  6. Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).

    Time frame: Within 4 days after the toddler dose (15 months of age)

    Local reactions were reported 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 and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

  7. Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

    Time frame: Within 4 days after Dose 1 of the infant series (2 months of age)

    Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  8. Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

    Time frame: Within 4 days after Dose 2 of the infant series (4 months of age)

    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  9. Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

    Time frame: Within 4 days after dose 3 of the infant series (6 months of age)

    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  10. Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).

    Time frame: Within 4 days after the toddler dose (15 months of age)

    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) 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, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
Oct 7, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.