Trials Sponsors Conditions Drugs Pricing

Conditions

Human Papillomavirus Vaccine

Keywords

HPV vaccination in healthy females

Outcome Measures

Primary Outcomes (14)

Antibodies measured by 9-valent HPV competitive Luminex immunoassay (cLIA) (mMU/mL)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
4 weeks after last vaccine dose
Acute allergic reaction (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Day of vaccination (day 0)
Injection site pain (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Days 0 to 6 after vaccination
Injection site redness (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Days 0 to 6 after vaccination
Injection site swelling (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Days 0 to 6 after vaccination

Secondary Outcomes (7)

Antibodies measured by 9-valent HPV cLIA (mMU/mL)
12 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
24 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
36 months after first vaccination
Antibodies measure by 9-valent HPV total IgG (TIgG)
4 weeks after last vaccine dose
Antibodies measure by 9-valent HPV TIgG
12 months after first vaccination
+2 more secondary outcomes

Study Arms (5)

15 to 26 years - 3 dose

ACTIVE COMPARATOR

9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses

9 to 14 years - 2 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

4 to 8 years - 2 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

Interventions

9-valent human papillomavirus vaccine (Gardasil 9) - 3 dosesBiological

0.5mL intramuscular dose - 3 doses (0, 2 and 6 months)

15 to 26 years - 3 dose

9-valent human papillomavirus vaccine (Gardasil 9) - 2 dosesBiological

0.5mL intramuscular dose - 2 doses (0 and 6 months)

4 to 8 years - 2 dose

Eligibility Criteria

Age4 Years - 26 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsParticipant is of female sex (based on participant/parent self-report)

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Signed/thumb-printed informed consent obtained from the participant's parent (4 to 17 year-olds) or signed/thumb-printed informed consent obtained from the participant (18 years and above)

Sponsors & Collaborators

London School of Hygiene and Tropical Medicine
Otherlead
University of Cambridge
Othercollaborator
Merck Sharp & Dohme LLC

Study Sites (1)

Ed Clarke

Banjul, Outside U.S. and Canada, PO Box 273, The Gambia

Related Publications (1)

Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Study Officials

Ed Clarke, MB ChB PhD
Medical Research Council @ LSHTM
PRINCIPAL INVESTIGATOR

Enrollment

1,720 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

February 6, 2019

Study Start

September 14, 2019

Actual (reported)

HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (14)

Secondary Outcomes (7)

Study Arms (5)

15 to 26 years - 3 dose

9 to 14 years - 2 dose

4 to 8 years - 2 dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

9 to 14 years - 1 dose

4 to 8 years - 1 dose

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (14)

Secondary Outcomes (7)

Study Arms (5)

15 to 26 years - 3 dose

9 to 14 years - 2 dose

4 to 8 years - 2 dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

9 to 14 years - 1 dose

4 to 8 years - 1 dose

You may not qualify if:

Source record

Locations