Pneumococcal InfectionsPhase 3PNEU-WAY PEDNCT03921424

Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

A Phase 3 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114, Prevnar 13™ and PNEUMOVAX™23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 407 participants
Where: 13 sitesin 3 countries
Study dates: 5 Nov 2019to 3 May 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) <50,000 copies/mL
Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1)
Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1)
Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last dose of the study vaccine.

Who cannot join

History of World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months
History of invasive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease
Bleeding disorder contraindicating intramuscular vaccinations
History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Show all 12Show fewer

Female participant: positive urine or serum pregnancy test
Expect to receive any pneumococcal vaccine during the study outside of the protocol
Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received a blood transfusion or blood products within 6 months of enrollment
Participated in another clinical study of an investigational product within 2 months of enrollment
Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence

Trial locations and contacts

13 sites in 3 countries.

Country

City, postcode or hospital

13 sites in 3 countries

Ukraine5 sites

Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)
Dnipro, Dnipropetrovsk Oblast, 49006
Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)
Dnipro, Dnipropetrovsk Oblast, 49115
Odesa Regional Center of Socially Significant Diseases ( Site 0083)
Odesa, Odesa Oblast, 65014
Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)
Vinnytsia, Vinnytsia Oblast, 21000
Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)
Zaporizhzhya, Zaporizhzhia Oblast, 69063

Other trials in Ukraine

South Africa4 sites

Family Clinic Research With UBUNTU ( Site 0045)
Cape Town, Western Cape, 7505
Perinatal HIV Research Unit ( Site 0042)
Johannesburg, Gauteng, 1864
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)
Johannesburg, Gauteng, 2001
Be Part Yoluntu Centre ( Site 0041)
Paarl, Western Cape, 7626

Other trials in South Africa

Thailand4 sites

Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)
Amphoe Mueang, Changwat Khon Kaen, 40002
Chulalongkorn University-Pediatrics ( Site 0062)
Bangkok, Bangkok, 10330
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)
Bangkok, Bangkok, 10700
CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)
Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Children Infected With Human Immunodeficiency Virus (HIV) (PNEU-WAY PED)

This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.

Conditions: Pneumococcal Infections
Being tested: V114, Prevnar 13™, PNEUMOVAX™23
Keywords: Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V114Biological
Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.
Prevnar 13™Biological
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.
PNEUMOVAX™23Biological
23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

Study groups in NCT03921424
Study group	Role	What they receive
V114	Experimental	Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2) Receives: Biological: V114; Biological: PNEUMOVAX™23
Prevnar 13™	Active comparator	Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2) Receives: Biological: Prevnar 13™; Biological: PNEUMOVAX™23

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Measured: Through 14 Days after Vaccination 1 (Up to Day 14)
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Measured: Through 14 Days after Vaccination 1 (Up to Day 14)
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported.
Measured: Through 6 Months after Vaccination 1 (Up to Day 194)
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Measured: Day 30

Secondary outcomes (5)

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Measured: Through 14 Days after Vaccination 2 (Up to Day 84)
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Measured: Through 14 Days after Vaccination 2 (Up to Day 84)
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Measured: Day 30
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Measured: Week 12
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20193 May 2021

First posted19 Apr 2019
Study start5 Nov 2019
Primary completion3 May 2021
Study completion3 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03921424
Sponsor's protocol ID: V114-030
Other IDs: V114-030, 2019-000341-12, 2019
Acronym: PNEU-WAY PED
Status last verified: May 2023
First submitted: 17 Apr 2019
Last updated: 7 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S, Chukhalova I, Dagan R, Richmond P, Mikviman E, Morgan L, Feemster K, Lupinacci R, Chiarappa J, Madhi SA, Bickham K, Musey L; V114-030 Study Group. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17.
PubMed 36939067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Children Infected With Human Immunodeficiency Virus (HIV) (PNEU-WAY PED)
ClinicalTrials.gov ID: NCT03921424
Acronym / sponsor ID: PNEU-WAY PED / V114-030
Conditions: Pneumococcal Infections
Keywords: Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 407 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 5 Nov 2019 (actual)
Primary completion: 3 May 2021 (actual)
Study completion: 3 May 2021 (actual)
First posted: 19 Apr 2019 (actual)
Results: Posted 9 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V114	Experimental	Biological: V114, Biological: PNEUMOVAX™23Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
Prevnar 13™	Active comparator	Biological: Prevnar 13™, Biological: PNEUMOVAX™23Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) <50,000 copies/mL
Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1)
Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1)
Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last dose of the study vaccine.

Key exclusion criteria (12 listed)

History of World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months
History of invasive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease
Bleeding disorder contraindicating intramuscular vaccinations

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V114Also: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.	Biological	V114
Prevnar 13™13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.	Biological	Prevnar 13™
PNEUMOVAX™2323-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose	Biological	Prevnar 13™, V114

Primary outcome

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study
Time frame: Through 6 Months after Vaccination 1 (Up to Day 194)
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported.
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Time frame: Day 30
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.

5 secondary outcomes

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Time frame: Day 30
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Time frame: Week 12
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Time frame: Week 12

Results and safety

Results posted to the registry on 9 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V114	203	203
Prevnar 13™	204	201

Primary outcome: Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™

Time frame: Through 14 Days after Vaccination 1 (Up to Day 14). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 n = 203	Prevnar 13™ n = 204
Injection site redness/erythema	9.4 (5.7)	5.9 (3.1)
Injection site hard lump/induration	10.3 (6.5)	6.4 (3.4)
Injection site tenderness/pain	55.2 (48.1)	53.9 (46.8)
Injection site swelling	28.6 (22.5)	21.6 (16.1)

Population analysed: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Primary outcome: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™

Time frame: Through 14 Days after Vaccination 1 (Up to Day 14). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 n = 203	Prevnar 13™ n = 204
Joint pain/arthralgia	9.4 (5.7)	10.3 (6.5)
Tiredness/fatigue	7.9 (4.6)	8.3 (4.9)
Headache	14.8 (10.2)	10.8 (6.9)
Muscle pain/myalgia	34.0 (27.5)	25.5 (19.7)
Hives or welts/urticaria	0.5 (0.0)	1.5 (0.3)

Population analysed: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Primary outcome: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study

Time frame: Through 6 Months after Vaccination 1 (Up to Day 194). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 n = 203	Prevnar 13™ n = 204
Vaccination 1	0.0 (0.0 to 1.8)	0.0 (0.0 to 1.8)
Vaccination 2	0.0 (0.0 to 1.8)	0.0 (0.0 to 1.8)

Population analysed: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not analyzed for Vaccination 2.

Primary outcome: Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™

Time frame: Day 30. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	V114 n = 203	Prevnar 13™ n = 204
Serotype 1 (Shared)	2.17 (1.89 to 2.48)	3.26 (2.82 to 3.77)
Serotype 3 (Shared)	1.05 (0.93 to 1.19)	0.84 (0.73 to 0.97)
Serotype 4 (Shared)	2.59 (2.23 to 3.00)	4.27 (3.57 to 5.11)
Serotype 5 (Shared)	2.94 (2.44 to 3.54)	2.78 (2.30 to 3.37)
Serotype 6A (Shared)	7.98 (6.30 to 10.11)	7.56 (6.06 to 9.45)
Serotype 6B (Shared)	11.44 (9.07 to 14.43)	6.92 (5.45 to 8.79)
Serotype 7F (Shared)	4.84 (4.10 to 5.71)	5.00 (4.29 to 5.83)
Serotype 9V (Shared)	4.15 (3.56 to 4.85)	4.78 (4.03 to 5.66)

Population analysed: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114	1 of 203 (0.5%)	158 of 203 (77.8%)	0 of 203
Prevnar 13™	1 of 204 (0.5%)	138 of 204 (67.6%)	0 of 204
V114 (Post-PNEUMOVAX™23)	2 of 203 (1%)	152 of 203 (74.9%)	0 of 203
Prevnar 13™ (Post-PNEUMOVAX™23)	2 of 202 (1%)	154 of 202 (76.2%)	0 of 202

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36939067Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S, Chukhalova I, Dagan R, Richmond P, Mikviman E, Morgan L, Feemster K, Lupinacci R, Chiarappa J, Madhi SA, Bickham K, Musey L; V114-030 Study Group. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

13 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Ukraine, South Africa, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ (time frame: Through 14 Days after Vaccination 1 (Up to Day 14)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03921424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.