A clinical study evaluating the safety, tolerability, and immune response to HPV vaccine given together with Bivalent RLP2086 vaccine in healthy subjects = 11 to < 18 years of age.

• Conditions: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.; MedDRA version: 14.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-002137-38-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-23
• Last Update Posted: 27 May 2013

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
2. Parent/legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3. Male or female subject aged =11 and <18 years at the time of enrollment.
4. Available for the entire study period and can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination and judgment of the investigator.
6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study (through the follow-up phone contact at month 12). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Section 4.5 for further information.
7. Negative urine pregnancy test for all female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Previous vaccination with any HPV vaccine.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Gardasil® or any HPV vaccine.
5. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
8. History of any sexually transmitted disease.
9. History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
10. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
11. Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
12. Current chronic use of systemic antibiotics.
13. Participation in other studies during study participation. Participation in purely observational studies is acceptable.
14. Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
15. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
17. Subjects who are investigational site staff members or relatives of those site staff members, or who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees.
18. Subject is pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified