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Completed

NCT Number: NCT01461993

A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17

This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.

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Key information

Conditions

Vaccines Meningococcal Vaccines

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Coastal Clinical Research Inc., Daphne, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects from 11 to 17 years old at the time of they start the study.
  • Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.

Exclusion criteria

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Previous vaccination with any HPV vaccine.
  • Contraindication to vaccination with Gardasil or any HPV vaccine.

Treatment and study plan

rLP2086 and Gardasil

Biological

Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.

rLP2086

Biological

Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.

GARDASIL

Biological

Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Primary outcomes

  1. Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens

    Time frame: 1 month after Vaccination 3

  2. Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]

    Time frame: 1 month after Vaccination 3

  3. Percentage of Participants With at Least One Adverse Event (AE)

    Time frame: Vaccination 1 up to 1 month after Vaccination 3

Secondary outcomes

  1. Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)

    Time frame: 1 month after Vaccination 3

  2. Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants

    Time frame: Before vaccination 1

  3. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

    Time frame: Before vaccination 1, 1 month after vaccination (Vac) 2, 3

  4. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

    Time frame: Before Vaccination 1, 1 month after Vaccination 2, 3

  5. Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)

    Time frame: Before Vaccination 1, 1 month after Vaccination 2, 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2011
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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