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OpenTrials
Completed

NCT Number: NCT01352793

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

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Key information

Conditions

Meningitis, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Australian Clinical Research Network, Maroubra, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects aged 10 to 25 years.

Exclusion criteria

  • Previous vaccination with Hepatitis A virus vaccine
  • Previous vaccination with investigational meningococcal B vaccine
  • History of culture-proven N. meningitidis serogroup B disease
  • Any neuroinflammatory or autoimmune condition
  • Any immune defect that would prevent an effective response to the study vaccine

Treatment and study plan

rLP2086 vaccine

Biological

120 mcg, 3 doses, at month 0, 2, and 6.

Control

Biological

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Primary outcomes

  1. Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study

    Time frame: Vaccination 1 up to 6 months after Vaccination 3

    An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.

  2. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1

    Time frame: Within 30 days after Vaccination 1

    A medically attended AE was defined as a non-serious AE that required medical attention.

  3. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2

    Time frame: Within 30 days after Vaccination 2

    A medically attended AE was defined as a non-serious AE that required medical attention.

  4. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3

    Time frame: Within 30 days after Vaccination 3

    A medically attended AE was defined as a non-serious AE that required medical attention.

Secondary outcomes

  1. Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods

    Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  2. Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods

    Time frame: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)

    A medically attended AE was defined as a non-serious AE that required medical attention.

  3. Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods

    Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)

    A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  4. Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods

    Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  5. Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination

    Time frame: Within 30 minutes after Vaccination 1, 2, 3

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  6. Number of Days Participant Missed School or Work Due to Adverse Events (AEs)

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 12, 2011
Registry last updated
Mar 11, 2015

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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