Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029) (NCT NCT00380367)

Last Updated: 2023-05-31

Results Overview

Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine were reported. The quadrivalent HPV competitive cLIA (v2.0) was used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination with the HPV quadrivalent vaccine. Seropositivity cutoffs of the HPV cLIAs were assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants who were highly likely to be seropositive. Any sample with a value less than the cutoffs was considered serostatus negative. Samples with values equal to or greater than the cutoff were considered serostatus positive. The cutoffs for the HPV 6, 11, 16, and 18 cLIAs were 20 milli-Merck units per milli liter (mMU/mL), 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

110 participants

Primary outcome timeframe

One month post-dose 3 (Month 7)

Results posted on

2023-05-31

Participant Flow

First Patient In (FPI): 03 May 2007 Last Patient Out (LPO): 04 Feb 2008 Multi-center study. Seven sites participated in the study. All sites were medical centers located in Bangalore, Mumbai and Pune.

Open-label, single-arm, nonrandomized study. Females \>9 to 15 years of age, who have not had coitarche and did not plan on becoming sexually active through the course of the study, who did not have a feverish feeling within 24 hours prior to the first injection, were included in the study.

Participant milestones

Participant milestones
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Overall Study STARTED	110
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) n=110 Participants Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Age, Continuous	11.54 years STANDARD_DEVIATION 1.67 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Body Mass Index (BMI)	16.76 Kg/m2 STANDARD_DEVIATION 2.79 • n=5 Participants
Height	143.32 Cm STANDARD_DEVIATION 9.58 • n=5 Participants
Weight	34.90 Kg STANDARD_DEVIATION 8.81 • n=5 Participants

PRIMARY outcome

Timeframe: One month post-dose 3 (Month 7)

Population: Per-Protocol (P-P) immunogenicity population: All participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were sero-negative at Day 1 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.

Outcome measures

Outcome measures
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) n=105 Participants Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 Anti-HPV 6 (n=99)	96.97 percentage of participants Interval 93.59 to 100.35
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 Anti-HPV 11 (n=105)	99.05 percentage of participants Interval 97.19 to 100.91
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 Anti-HPV 16 (n=105)	99.05 percentage of participants Interval 97.19 to 100.91
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 Anti-HPV 18 (n=105)	99.05 percentage of participants Interval 97.19 to 100.91

PRIMARY outcome

Timeframe: Up to 7 months

Population: Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant's Vaccination Report Card daily for 14 days after each vaccination (Days 1-15). The number of participants who experienced ≥1 AE, the number of participants who experienced ≥1 injection site AE, the number of participants who experienced ≥1 systemic AE, and the number of participants who experienced ≥1 vaccine-related AE were reported for the Safety Cohort.

Outcome measures

Outcome measures
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) n=108 Participants Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study Any AE	63 participants
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study Injection site AE	50 participants
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study Systemic AE	35 participants
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study Vaccine-related AE	45 participants

Adverse Events

Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) n=108 participants at risk Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
Ear and labyrinth disorders Vertigo	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Gastrointestinal disorders Abdominal Pain	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Gastrointestinal disorders Diarrhoea	1.9% 2/108 • Number of events 2 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Gastrointestinal disorders Vomiting	1.9% 2/108 • Number of events 2 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Asthenia	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Flank pain	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Pyrexia	23.1% 25/108 • Number of events 25 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Infections and infestations Nasopharyngitis	7.4% 8/108 • Number of events 8 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Infections and infestations Pharyngitis	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Nervous system disorders Headache	4.6% 5/108 • Number of events 5 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Nervous system disorders Somnolence	0.93% 1/108 • Number of events 1 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 4/108 • Number of events 4 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Injection site pain	42.6% 46/108 • Number of events 83 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Injection site tenderness	23.1% 25/108 • Number of events 41 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Injection site erythema	12.0% 13/108 • Number of events 20 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
General disorders Injection site swelling	9.3% 10/108 • Number of events 16 • Up to 7 months Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER