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Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

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ClinicalTrials.gov Identifier: NCT00708682
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : February 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Biological: 13-valent pneumococcal conjugate vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Biological: 13-valent pneumococcal conjugate vaccine



Primary Outcome Measures :
  1. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]
    Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series [ Time Frame: 1 month after dose 2 of the infant series (5 months of age) ]
    Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants.

  2. Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]
    Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants.


Other Outcome Measures:
  1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series [ Time Frame: Dose 2 of infant series (4 months of age) ]
    Antibody GMC 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 evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

  2. GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series [ Time Frame: Dose 3 of infant series (6 months of age) ]
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

  3. GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose [ Time Frame: Toddler Dose (12 months of age) ]
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.

  4. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 of 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 or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.

  5. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 of 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 or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.

  6. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (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 or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.

  7. Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 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 or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.

  8. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 of Infant Series (2 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  9. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 of Infant Series (4 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  10. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 of Infant Series (6 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

  11. Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.



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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
  • Able to complete three blood draws during study
  • At least 3.5 kg at enrollment

Exclusion Criteria:

  • Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
  • Immune deficiency, bleeding disorder or significant chronic medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708682


Locations
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Mexico
Guadalajara, Jalisco, Mexico, 44080
Morelia, Michoacan, Mexico, 58070
Cuernavaca, Morelos, Mexico, 62508
Monterrey, Nuevo Leon, Mexico, 64460
Merida, Yucatan, Mexico, 9700
Distrio Federal, Mexico, 14080
Distrio Federal, Mexico, 4530
Oaxaca, Mexico, 71220
Puebla, Mexico, 72190
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00708682    
Other Study ID Numbers: 6096A1-3009
First Posted: July 2, 2008    Key Record Dates
Results First Posted: February 25, 2011
Last Update Posted: October 25, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs