Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373958
• Other study ID #: 6096A1-004
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2006
• Last updated: January 17, 2013
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2013
• Source: 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 evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• 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, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13 valent pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
• 7vPnc pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Antibody Level =0.35 µg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	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 the 3-dose infant series (7 months of age)	No
Primary	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Antibody concentration/geometric mean concentration 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.	1 Month After the Toddler Dose	No
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).	One Month After the Infant Series (7 months of age)	No
Primary	Percentage of Participants Reporting Pre-specified Systemic Events	Systemic events (any fever [Fv] = 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after each dose	Yes
Primary	Percentage of Participants Reporting Pre-specified Local Reactions	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling 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 have been represented in more than 1 category.	Within 7 days after each dose	Yes
Secondary	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)		One month after toddler dose (13 to 16 months of age)	No
Secondary	Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose		one month after the toddler dose	No
Secondary	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.	one month after the toddler dose	No
Secondary	Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose		one month after the toddler dose	No
Secondary	Percentage of Participants Achieving Functional Antibody Titer =1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Percentage of participants achieving functional antibody titer =1:8 as measured by opsonophagocytic activity assay (OPA) 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 and one month after toddler dose	No
Secondary	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.	one month after the infant series and the toddler dose	No