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

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474539
• Other study ID #: 6096A1-3007
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2007
• Last updated: January 22, 2013
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United 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 (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion Criteria:

• Healthy 2-month-old infants

• Available for the entire study period

Exclusion criteria:

• Previous vaccination with any vaccine before the start of the study

• Known contraindication to vaccination

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age
• 7-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age

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

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(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 (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever [Fv] = 37.5 degrees Celsius [C], fever = 38 C but = 39 C, fever >39 C but = 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), 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
Primary	Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer = 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series	Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (=) 1:8 along with the corresponding 95% confidence interval (CI) are presented.	One month after infant series dose (at 5 months of age)	No
Primary	Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose		One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)	No
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose	Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).	One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No
Primary	Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose		One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No
Primary	Percentage of Participants Achieving Antibody Level = 0.35µg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold = 0.35 µg/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.	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No
Primary	Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No
Secondary	Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer = 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Percentage of participants achieving a meningococcal C SBA serum antibody titer = 1:8 along with the corresponding 95% confidence interval (CI) are presented.	One month after toddler dose (at 16 months of age)	No