Papillomavirus Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.
Interventions
Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Females Age 9 To 15 Years * Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study * No Fevers 24 Hours Prior To The First Injection
Exclusion criteria
* Participant Had Received A Prior Vaccination With A HPV Vaccine * Participant Has Allergies To Vaccine Component Including Aluminum And Yeast * Participant Has (Human Immunodeficiency Virus) HIV Infection * Participant Is Immunocompromised * Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection * Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 | One month post-dose 3 (Month 7) | 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. |
| Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study | Up to 7 months | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) |
|---|---|
| Age, Continuous | 11.54 years STANDARD_DEVIATION 1.67 |
| Body Mass Index (BMI) | 16.76 Kg/m2 STANDARD_DEVIATION 2.79 |
| Height | 143.32 Cm STANDARD_DEVIATION 9.58 |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 34.90 Kg STANDARD_DEVIATION 8.81 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study | Any AE | 63 participants |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study | Systemic AE | 35 participants |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |
Primary
Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |
| Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) | 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 |