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CompletedNCT04978818Updated Jun 24, 2024Results posted

Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

A Phase 4 interventional study of Vaxelis and PedvaxHIB in Haemophilus Influenzae Type B Infection, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 5 sites in United States. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
333
Allocation
Randomized
Ages
6 Weeks to 12 Weeks
Sex
All
01

Study summary

The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Read the detailed description

Historically, American Indian and Alaska Native (AI/AN) children aged \<5 years have experienced invasive H. influenzae type b (Hib) disease at a rate that is at least 5 times higher than the general U.S. population. In the pre-vaccine era, the incidence of Hib disease peaked earlier for AI/AN children at 4-5 months than general US children at 6-9 months. Therefore, prevention efforts for AI/AN populations focused on identifying a vaccine that would protect against disease in early infancy. Studies in AI/AN children revealed that the Hib conjugate vaccine with the capsular polysaccharide (polyribosylribitol phosphate polysaccharide [PRP]) coupled to the outer membrane protein complex of Neisseria meningitidis (OMP) induced anti-PRP IgG titers that correlated with protection (GMC ≥0.15 μg/mL) and demonstrated high efficacy after a single dose in infancy. Hib PRP-OMP was licensed in 1991 as PedvaxHIB; following introduction of a two-dose primary series and a booster dose, the rate of Hib disease decreased substantially among AI/AN children. The importance of PRP-OMP vaccine to disease control was highlighted in the 1990s in Alaska when use of a non-PRP OMP Hib vaccine was associated with an increase in disease incidence in AN children. In 1999, the American Academy of Pediatrics Committee for Native American Child Health released its official preference for Hib PRP-OMP for use in AI/AN populations.

In spite of Hib vaccine coverage similar to or greater than the national average, AI/AN populations periodically experience pediatric cases of invasive Hib disease. In contrast to the pre-Hib vaccine era, a majority of these cases occur in fully vaccinated children beyond the first year of life. This epidemiologic shift in the age at which disease occurs may indicate ongoing transmission in the presence of waning immunity following vaccination.

Vaxelis is a licensed hexavalent combination vaccine that contains Hib PRP-OMP and antigens (Hepatitis B surface antigen, Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis [DTaP], and Inactivated Polio Virus [IPV]) to protect against diseases caused by 5 other organisms. Vaxelis contains 3.0 µg/mL of PRP-OMP antigen, compared to 7.5 µg/mL in PedvaxHIB. This lower concentration of PRP-OMP has been shown to be less reactogenic and similarly immunogenic to higher doses. Vaxelis is approved for administration as a 3-dose primary series at 2, 4, and 6 months of age. A booster dose with a different licensed Hib vaccine (e.g., PedvaxHIB, ActHib) is required at 12-15 months. Vaxelis Hib PRP-OMP was found to be highly immunogenic post-dose 2 at 4 months and post-dose 3 at 6 months. However, immunogenicity post-dose 1 was not measured in the phase 3 clinical trials of this vaccine.

In June 2019, the CDC's Advisory Committee on Immunization Practices (ACIP) passed a resolution supporting inclusion of Vaxelis in the Vaccines For Children Program for the general U.S. population. This vaccine was made available for routine use in the U.S. in 2021. A preferential recommendation for use of this vaccine in AI/AN children was not given because post-dose 1 immunogenicity data were not available. To support policy recommendations to protect the health of the AI/AN community, a study is needed to assess non-inferiority of the post-dose 1 immune response to Vaxelis compared to the current recommended product (PedvaxHIB). It is important to demonstrate that infants vaccinated with Vaxelis will be protected early in life, given the historic early peak of Hib disease and the evidence that Hib still circulates in village-based and reservation-based AI/AN communities.

If this study finds that Vaxelis and PedvaxHIB provide comparable protection after one dose, this would support the ACIP making a preferential recommendation for Vaxelis for AI/AN infants. This would expand the options of preferred vaccines for AI/AN infants and potentially provide more long-lasting protection given that 3 doses would be given as part of the primary series.

This study is a prospective, randomized, unblinded, phase IV study of the immunogenicity of two licensed Hib vaccines among AI/AN infants. The study will enroll approximately 330 AI/AN infants on Navajo Nation, on White Mountain Apache (WMA) Tribal lands, and in Anchorage, Alaska who are 6-12 weeks of age and due to receive their first set of routine infant immunizations. Eligible infants whose parents provide written informed consent will be block randomized to one of two study arms - either Vaxelis or PedvaxHIB. Participants will make 5 study visits over the course of approximately 5 months. Participants randomized to the Vaxelis group will receive the vaccination at 2, 4 and 6 months of age, and randomized to the PedvaxHIB group will receive the vaccination at 2 and 4 months of age.

Four blood samples will be collected: at ages 2, 3, 6, and 7 months. These specimens will be tested by ELISA to assess anti-PRP antibody levels. Among infants vaccinated at 2 months of age, the anti-PRP IgG GMC 30 days post dose 1 of Vaxelis will be considered non-inferior if the ratio of the GMC in the Vaxelis group relative to the PedvaxHIB group is >0.67. The statistical criterion we are using to define non-inferiority corresponds to the lower bound of the two-sided 95% confidence interval (CI) on the anti-PRP IgG GMC ratio [Vaxelis / PedvaxHIB] being >0.67. A sample size of 150 evaluable children per group will provide at least 80% power to detect non-inferiority using constrained longitudinal analysis.

Each participant will also be given other routine pediatric immunizations that are not part of the study regimen, per ACIP schedule and recommendations, (e.g., DTaP and IPV at 2, 4 and 6 months, and hepatitis B vaccine at 2 and 6 months, for participants randomized to PedvaxHIB; Prevnar13 at 2, 4 and 6 months, and the rotavirus vaccine series at either 2, 4 and 6 months (if given RotaTeq) or 2 and 4 months (if given Rotarix). Inactivated influenza vaccine will be offered at 6 months of age, as appropriate based on season.

02

Conditions studied

  • Haemophilus Influenzae Type B Infection

Keywords

  • Native American
  • Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 333 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Born at gestational age of ≥35 weeks
  • AI/AN infant between 6 to 12 weeks of age (42-90 days) at the time of the first vaccination (i.e., Study Day 1)
  • Written informed consent provided by parent(s)/Legally Authorized Representative(s) (LARs)
  • Investigators believe that the parent(s)/LARs can and will comply with the requirements of the protocol (i.e., return for follow-up visits, recall of adverse events)
  • Infant is available to complete the follow-up period of 5 months
  • Healthy infant, as established by medical history and clinical examination before entering the study

Exclusion criteria

Exclusion Criteria:

  • History of receipt of blood, blood products, or immunoglobulin products since birth or expected receipt through the duration of the study
  • Chronic seizure or evolving or unstable neurologic disorder
  • Congenital Heart Disease, except for uncomplicated CHD (e.g., PDA, small septal defect)
  • Infant of mother with HIV infection
  • History of reaction or hypersensitivity likely to be exacerbated by any vaccine component, or to latex
  • Infant with confirmed or suspected immunocompromising medical condition, based on medical history, including chronic administration (more than 14 days in the lifetime) of immunosuppressants or other immune-modifying drugs since birth
  • Administration of infant vaccines other than birth dose Hepatitis B, prior to the time of enrollment
  • Any condition which might interfere with the evaluation of the investigational product, or interpretation of subject safety or study results, in the opinion of the investigator
  • Child of an employee of the sponsor, clinical study site, or any other individual involved with the conduct of the study, or an immediate family member of such individuals
  • Acute illness and/or fever (temperature ≥100.4 F or ≥38.0 C) at time of enrollment (Note: Participant with fever may be enrolled at later date if symptoms have resolved and all other criteria for inclusion are met at that time)
  • Current (or within the past 7 days) or expected receipt of immunosuppressive agents, including steroids, except topical or inhaled steroids (Note: For oral corticosteroids, this will mean prednisone (≥ 0.5 mg/kg/day, or equivalent; participant may be enrolled at a later date if medication use ends and all other criteria for inclusion are met at that time)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
333 participants (actual)

Study arms

  • Active comparator
    Vaxelis

    165 infants will be randomized to the Vaxelis group, which is licensed for primary vaccination at 2, 4 and 6 months of age.

    Drug: Vaxelis

  • Active comparator
    PedvaxHIB arm

    165 infants will be randomized to the PedvaxHIB group, which is licensed for primary vaccination at 2 and 4 months of age.

    Drug: PedvaxHIB

Interventions

  • DrugVaxelis

    Eligible infants will be block randomized to one of two study arms.

    Also known as: Intervention

  • DrugPedvaxHIB

    Eligible infants will be block randomized to one of two study arms.

    Also known as: Comparator

06

What researchers measure

Primary outcomes

  1. Anti-PRP IgG Geometric Mean Concentration (GMC)

    The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.

    Time frame: 30 days after dose 1

Secondary outcomes

  1. Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1

    Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

    Time frame: 30 days after dose 1 of Vaxelis or PedvaxHIB

  2. Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1

    Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

    Time frame: 30 days after dose 1 of Vaxelis or PedvaxHIB

  3. Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121

    Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

    Time frame: 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

  4. Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121

    Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

    Time frame: 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

  5. Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151

    Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

    Time frame: 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB

  6. Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151

    Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

    Time frame: 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB

07

Results

Posted Jun 24, 2024

Participant flow

American Indian and Alaska Native (AI/AN) infants receiving primary care at five Indian Health Service (IHS)/Tribal Health facilities in Alaska and the Navajo Nation were recruited from December 2021 to April 2023. The first participant was enrolled in January 2022.

Participant flow — Overall Study
MilestonePedvaxHIB ArmVaxelis
Started166167
Completed144152
Not completed2215

Outcome measures

PrimaryAnti-PRP IgG Geometric Mean Concentration (GMC)

The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.

Time frame:
30 days after dose 1
Reported as:
Geometric mean · μg/mL
Anti-PRP IgG Geometric Mean Concentration (GMC)
μg/mLPedvaxHIB ArmVaxelis
Anti-PRP IgG Geometric Mean Concentration (GMC)0.40 (0.31 to 0.5)0.41 (0.33 to 0.51)
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Constrained Longitudinal Analysis · p = 0.85 · Ratio of geometric mean concentration: 1.03 · 95% CI 0.75 to 1.41The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.
SecondaryPercent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

Time frame:
30 days after dose 1 of Vaxelis or PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1104115
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.39
SecondaryPercent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

Time frame:
30 days after dose 1 of Vaxelis or PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 14038
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.64
SecondaryPercent of Anti-PRP IgG ≥0.15 µg/mL on Day 121

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

Time frame:
60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121115126
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.87
SecondaryPercent of Anti-PRP IgG ≥1.0 µg/mL on Day 121

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

Time frame:
60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121100102
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.3
SecondaryPercent of Anti-PRP IgG ≥0.15 µg/mL on Day 151

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

Time frame:
30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151106122
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.15
SecondaryPercent of Anti-PRP IgG ≥1.0 µg/mL on Day 151

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

Time frame:
30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB
Reported as:
Count of participants · Participants
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151
ParticipantsPedvaxHIB ArmVaxelis
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 15184107
Statistical analysis
  • PedvaxHIB Arm vs Vaxelis · Chi-squared · p = 0.03

Adverse events

Collected over Up to 7 months post first dose of study vaccine. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PedvaxHIB Arm0/166 (0%)12/166 (7.2%)—
Vaxelis0/167 (0%)9/167 (5.4%)—
Most frequent serious events
Most frequent serious events
EventPedvaxHIB ArmVaxelis
BronchiolitisRespiratory, thoracic and mediastinal disorders8/1664/167
COVID-19Respiratory, thoracic and mediastinal disorders2/1661/167
InfluenzaRespiratory, thoracic and mediastinal disorders2/1660/167
Serizure, or seizure-like activityNervous system disorders0/1662/167
Broken FemurMusculoskeletal and connective tissue disorders1/1660/167
Viral illness with hypoxiaInfections and infestations1/1660/167
Acute gastroenteritisGastrointestinal disorders0/1661/167
Urinary Tract InfectionRenal and urinary disorders0/1661/167
Viral Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders0/1661/167

Baseline characteristics

Age, Continuous
Age, Continuous(Days)PedvaxHIB ArmVaxelisTotal
Median59 (45 to 63)60 (46 to 63)60 (46 to 63)
Sex: Female, Male
Sex: Female, Male(Participants)PedvaxHIB ArmVaxelisTotal
Female9283175
Male7484158
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PedvaxHIB ArmVaxelisTotal
American Indian or Alaska Native166167333
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

5 sites
  • Alaska Native Medical Center
    Anchorage, Alaska 99508, United States
  • Chinle Center for Indigenous Health
    Chinle, Arizona 86503, United States
  • Fort Defiance Center for Indigenous Health
    Fort Defiance, Arizona 86504, United States
  • Gallup Center for Indigenous Health
    Gallup, New Mexico 87301, United States
  • Shiprock Center for Indigenous Health
    Shiprock, New Mexico 87420, United States
09

References and documents

Publications

  • Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406. PubMed 27846055 ↗
  • Bulkow LR, Wainwright RB, Letson GW, Chang SJ, Ward JI. Comparative immunogenicity of four Haemophilus influenzae type b conjugate vaccines in Alaska Native infants. Pediatr Infect Dis J. 1993 Jun;12(6):484-92. doi: 10.1097/00006454-199306000-00006. PubMed 8345981 ↗
  • Santosham M, Wolff M, Reid R, Hohenboken M, Bateman M, Goepp J, Cortese M, Sack D, Hill J, Newcomer W, et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex. N Engl J Med. 1991 Jun 20;324(25):1767-72. doi: 10.1056/NEJM199106203242503. PubMed 1903846 ↗
  • Singleton R, Bulkow LR, Levine OS, Butler JC, Hennessy TW, Parkinson A. Experience with the prevention of invasive Haemophilus influenzae type b disease by vaccination in Alaska: the impact of persistent oropharyngeal carriage. J Pediatr. 2000 Sep;137(3):313-20. doi: 10.1067/mpd.2000.107843. PubMed 10969253 ↗
  • Diaz-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D, Bradshaw S, Martin JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. Vaccine. 2011 Feb 1;29(6):1324-31. doi: 10.1016/j.vaccine.2010.11.053. Epub 2010 Dec 4. PubMed 21134456 ↗
  • Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18. PubMed 27288217 ↗
  • State of Alaska Epidemiology Bulletin; Aug 11, 2009

Study documents

  • Protocol and statistical analysis plan · Jun 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04978818
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 27, 2021
Start date
Jan 27, 2022
Primary completion
Oct 26, 2023
Completion
Oct 26, 2023
Results posted
Jun 24, 2024
Last update
Jun 24, 2024

Study contacts

Laura Hammitt, MD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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