Last updated: 03/23/2020 12:50:05
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine in Healthy Non-Pregnant Women aged 18 to 40 Years
Trial description: The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Concentration of serotype Ia GBS IgG levels in healthy non-pregnant women
Timeframe: At Day 31 after a single vaccination
Concentration of serotype III GBS IgG levels in healthy non-pregnant women
Timeframe: At Day 31 after a single vaccination
Concentration of serotype Ib GBS IgG levels in healthy non-pregnant women
Timeframe: At Day 31 after a single vaccination
Secondary outcomes:
Number of subjects reporting solicited local and systemic Adverse Events (AEs)
Timeframe: From 6 hours through Day 7 post-vaccination
Number of subjects reporting any unsolicited AEs
Timeframe: From Day 1 to Day 181 (end of the study)
Number of subjects reporting any Serious Adverse Events (SAEs)
Timeframe: From Day 1 to Day 181 (end of the study)
Interventions:
Biological/vaccine: GBS Vaccine
Enrollment:
1053
Observational study model:
Not applicable
Primary completion date:
2015-23-04
Time perspective:
Not applicable
Clinical publications:
Jiri Beran, Geert Leroux-Roels, Pierre Vandamme, Jan de Hoon, Corinne Vandermeulen, Mohamed Al-Ibrahim, Casey Johnson, James Peterson, Sherryl Baker, Claudia Seidl, Annette Dreisbach, Annette Karsten, Bartholomew Corsaro, Ouzama Henry, Maria Lattanzi and Zourab Bebia. Safety and immunogenicity of fully liquid and lyophilized formulations of an investigational trivalent group B streptococcus vaccine in healthy non-pregnant women: Results from a randomized comparative phase II trial. Vaccine. 2020. 38(16):3227-3234.
Medical condition
Infections, Streptococcal
Product
GSK3536855A
Collaborators
Novartis Vaccines and Diagnostics
Study date(s)
November 2014 to September 2015
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 40 years
Accepts healthy volunteers
Yes
- 1. Healthy females 18-40 years of age, inclusive.
- 2. Individuals who have given written consent after the nature of the study has been
- 1. Individuals who are pregnant (urine pregnancy test at Study Day 1) or who anticipate
- becoming pregnant prior to the end of the study, Day 181 Visit.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Healthy females 18-40 years of age, inclusive. 2. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 4. Individuals who can comply with all study procedures and are available for follow-up.
Exclusion criteria:
- 1. Individuals who are pregnant (urine pregnancy test at Study Day 1) or who anticipate becoming pregnant prior to the end of the study, Day 181 Visit. 2. Individuals “of childbearing potential”, heterosexually active, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry and who will not continue to use acceptable contraceptive methods through to the end of the study, Day 181 Visit.
- Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- Acceptable birth control methods are defined as one or more of the following: hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; intrauterine device (IUD); monogamous relationship with vasectomized partner who was vasectomized for at least six months prior to the subject’s study entry; or abstinence/no sexual intercourse. 3. Individuals who are nursing (breastfeeding). 4. Individuals who have participated in any clinical trial with another investigational product 30 days prior to first study visit or who intend to participate in another trial prior to the end of the study, Day 181 Visit. 5. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens. 6. Individuals who receive:
- live vaccine 30 days prior to study vaccination
- inactivated vaccines 15 days prior to study vaccination
- any vaccines within 30 days after study vaccination
- exception: an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination 7. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to Study Day 1. 8. Individuals with acute or chronic infection(s) (e.g. requiring systemic antibiotic treatment or antiviral therapy) within 7 days prior to Study Day 1. 9. Individuals with a history of severe allergic reactions after previous vaccination or medication such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. 10. Individuals with known or suspected impairment of the immune system including known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder and receipt of immunosuppressive therapy. 11. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days prior to enrollment. Use of inhaled, intranasal, intra-articular, or topical corticosteroids is allowed. 12. Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 13. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome. 14. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 15. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. 16. Individuals with history or any illness that, in the opinion of the investigator, might interfere with results of the study or pose additional risk to subjects due to participation.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Redding, California, United States, 96001
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-23-04
Actual study completion date
2015-22-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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