Safety and Immunogenicity of Extended 2-dose Regimens of 9vHPV Vaccine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

8 Apr 2021 → ongoing

Decision date (initial)

2022-09-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

- · MERCK SHARP & DOHME LLC

External identifiers

EU CT number

2022-500256-37-00

EudraCT number

2020-003736-24

WHO UTN

U1111-1274-2496

ClinicalTrials.gov

NCT04708041

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Prophylaxis, Safety

1. In a population who are seronegative to the relevant HPV type at Day 1, to demonstrate that administration of a 2-dose regimen of 9vHPV vaccine in boys and girls 9 to 14 years of age induces noninferior cLIA GMTs of antibodies to each of the 9vHPV vaccine types compared with young women 16 to 26 years of age receiving a 3-dose regimen of the same vaccine at Day 1, Month 2, and Month 6.*
2. In 10- to 15-year-old boys and girls who received a single dose of 9vHPV vaccine at least 1 year prior to enrollment, to characterize the immune response to a second dose of 9vHPV vaccine (as measured by cLIA GMTs of antibodies to each of the 9vHPV vaccine types) at 4 weeks post dose 2 taking into account the time interval between administration of doses 1 and 2 (Cohort 0).
3. To evaluate the safety of administering the 9vHPV vaccine based on the dosing regimens investigated in this study.
*Four 2-dose cohorts (Cohorts 1-4) are compared to the 3-dose cohort (Cohort 5) in this objective. Cohort 1: 9-14-year-olds receiving 2 doses 12 months apart; Cohort 2: 9-13-year-olds receiving 2 doses 24 months apart; Cohort 3: 9-12-year-olds receiving 2 doses 36 months apart; Cohort 4: 9-10-year-olds receiving 2 doses 60 months apart; and Cohort 5: 16-26-year-old women receiving 3 doses.

Secondary objectives 3

1. Cohorts 1-5*: To estimate seroconversion at 4 weeks post last dose to each of the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
2. Cohorts 1-5*: To estimate seropositivity to each of the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12, 24, 36 months post last dose.
3. Cohorts 1-5*: To estimate anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 cLIA GMTs at 12, 24, and 36 months post last dose. *Cohort 1: 9-14-year-olds receiving 2 doses 12 months apart; Cohort 2: 9-13-year-olds receiving 2 doses 24 months apart; Cohort 3: 9-12-year-olds receiving 2 doses 36 months apart; Cohort 4: 9-10-year-olds receiving 2 doses 60 months apart; and Cohort 5: 16-26-year-old women receiving 3 doses

Conditions and MedDRA coding

Prevention of persistent anogenital HPV infection and disease caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Boys and girls 9 to 15 years must not have had coitarche and do not plan on becoming sexually active during the vaccination period
2. Women 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results
3. Women 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners
4. Cohort 0 participants must have received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

Exclusion criteria 10

1. Known allergy to any vaccine component
2. History of severe allergic reaction that required medical intervention
3. Thrombocytopenia or any coagulation disorder
4. Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
5. Currently immunocompromised, or been diagnosed with immunodeficiency
6. Had a splenectomy
7. Receiving or has received immunosuppressive therapies within the last year
8. Received any immunoglobulin product or blood-derived product within 3 months
9. Has received more than 1 dose of an HPV vaccine (Cohort 0)
10. Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay at 4 Weeks Post Last Vaccination
2. Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
3. Percentage of Participants With at Least 1 Systemic Adverse Event
4. Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event

Secondary endpoints 7

1. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 Weeks Post Last Vaccination
2. Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination
3. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination
4. Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination
5. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination
6. Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination
7. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme Corp.

Contact name

Rachael Bonawitz

Public contact point

Organisation

Merck Sharp & Dohme Corp.

Contact name

Rachael Bonawitz

Third parties 3

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications