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Completed

NCT Number: NCT00452790

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

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

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Key information

Conditions

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

Age range

42 day–72 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sector-12, Chandigarh, India

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants aged 6 weeks (42-72 days) at time of enrolment
  • Available for the entire study period

Exclusion criteria

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

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

1 dose at 6, 10, 14 weeks and 12 months of age

7 valent pneumococcal conjugate vaccine

Biological

1 dose at 6, 10, 14 weeks and 12 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 (18 weeks of age)

    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) are presented.

  2. Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.

    Time frame: 1 month after the infant series (18 weeks of age)

    Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) 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 the toddler dose (13 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, 2-sided 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 19 A) are presented.

Other outcomes

  1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series

    Time frame: 1 month after the 3-dose infant series (18 weeks 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.

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

    Time frame: 1 month after toddler dose (13 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.

  3. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)

    Time frame: Within 4 days after the dose 1 of the infant series (6 weeks of age)

    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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.

  4. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)

    Time frame: Within 4 days after the dose 2 of the infant series (10 weeks of age)

    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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.

  5. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)

    Time frame: Within 4 days after the dose 3 of the infant series (14 weeks of age)

    Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 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.

  6. Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)

    Time frame: Within 4 days after the toddler dose (12 months of age)

    Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 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.

  7. Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)

    Time frame: Within 4 days after the dose 1 of the infant series (6 weeks 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 (10 Weeks of Age)

    Time frame: Within 4 days after the dose 2 of the infant series (10 weeks 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.

  9. Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)

    Time frame: Within 4 days after the dose 3 of the infant series (14 weeks 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.

  10. Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)

    Time frame: Within 4 days after the toddler dose(12 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 27, 2007
Registry last updated
Mar 24, 2011

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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