Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.

Study Overview
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Brief Summary
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Two human papillomavirus vaccines are now commercially available. No clinical data exist regarding: The immunogenicity and safety of Gardasil and Twinrix when co-administered. The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil. The main objective of the first phase of this clinical trial was: • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls. The main objective of the seconde phase of this clinical trial is: • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil. Study Design & Duration: Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups. Duration of the study: Participants will be followed for the duration of 10 years post-primary vaccination. Number of Centres: One Center.

Official Title
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Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.

Conditions
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Human Papillomavirus

Intervention / Treatment
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* Biological: Gardasil vaccine, Immunogenicity, Booster dose.
* Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule. Exclusion Criteria: Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gardasil, Immunogenicity, Booster dose.<br> | Biological: Gardasil vaccine, Immunogenicity, Booster dose.<br>* Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.<br>* Other names: HPV vaccine;|
| Experimental: Cervarix, Immunogenicity, Booster dose.<br> | Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.<br>* Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.<br>* Other names: HPV vaccine.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody to HPV | The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil. | 1 month post booster dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil. |  | Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus Vaccines, Immunogenicity Gardasil Cervarix, Booster dose