Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Tetanus Clinical Trial

Official title:

An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ in Healthy Adolescents 11-17 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325130
• Other study ID #: V501-025
• Secondary ID: 2005_092
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2006
• Last updated: February 23, 2015
• Start date: April 2006
• Est. completion date: April 2007

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• Must be healthy boys or girls, 11-17 years of age

• Must be a virgin with no intention of becoming sexually active during the study period

• Must have been properly vaccinated against diphtheria, tetanus and pertussis

Exclusion Criteria:

• Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years

• Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Meningitis
• Neoplasms, Glandular and Epithelial
• Tetanus
• Whooping Cough

Intervention

Biological:
• Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
• Comparator: Menactra™ (Concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
• Comparator: Adacel™ (Concomitant)
a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
• Comparator: Menactra™ (Non-concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
• Comparator: Adacel™
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Reisinger KS, Block SL, Collins-Ogle M, Marchant C, Catlett M, Radley D, Sings HL, Haupt RM, Garner EI; Protocol 025 Investigators. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010 Jun;125 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 = 20 mMU/mL) by Week 4 Postdose 3 (7 Months)		7 Months	No
Primary	Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 = 16 mMU/mL) by Week 4 Postdose 3 (7 Months)		7 Months	No
Primary	Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 = 20 mMU/mL) by Week 4 Postdose 3 (7 Months)		7 Months	No
Primary	Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18= 24 mMU/mL) by Week 4 Postdose 3 (7 Months)		7 Months	No
Primary	Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™		7 Months	No
Primary	Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™		7 Months	No
Primary	Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™		7 Months	No
Primary	Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™		7 Months	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria = 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus = 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Primary	Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™		7 Months	No
Secondary	Acceptable Safety Profile		15 days post injection	No