Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study

ID
Name
H-41686
Description
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
Trial arms
Trial start
2022-09-26
Estimated PCD
2028-04-01
Trial end
2028-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Gardasil9
The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old.
Arms:
Single Arm
Other names:
GARDASIL®
Size
150
Primary endpoint
HPV6 antibodies at 13 months
13 months
HPV11 antibodies at 13 months
13 months
HPV16 antibodies at 13 months
13 months
HPV18 antibodies at 13 months
13 months
HPV31 antibodies at 13 months
13 months
HPV33 antibodies at 13 months
13 months
HPV45 antibodies at 13 months
13 months
HPV52 antibodies at 13 months
13 months
HPV58 antibodies at 13 months
13 months
HPV6 antibodies at 60 months
60 months
HPV11 antibodies at 60 months
60 months
HPV16 antibodies at 60 months
60 months
HPV18 antibodies at 60 months
60 months
HPV31 antibodies at 60 months
60 months
HPV33 antibodies at 60 months
60 months
HPV45 antibodies at 60 months
60 months
HPV52 antibodies at 60 months
60 months
HPV58 antibodies at 60 months
60 months
Eligibility criteria
Inclusion Criteria: 1. Children aged 4-8 years old 2. Receives care at the Boston Medical Center or one of the affiliated Community heath centers 3. Naïve to HPV Vaccine Exclusion Criteria: 1. A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast 2. Immunocompromised/previous immunosuppressive therapy 3. Thrombocytopenia or other coagulation disorder
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-10-04

1 organization

1 product

1 indication

Organization
Boston Medical Center
Product
Gardasil9
Indication
Human Papillomavirus