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A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

ConditionRespiratory Syncytial Virus Infections+Metapneumovirus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline

About this trial

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written informed consent obtained from the participant prior to performance of any study-specific procedure.

Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).

Body Mass Index (BMI) between 18 kg/m² and 33 kg/m², inclusive.

A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.

Disqualifiers

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).

Any medical condition that in the judgment of the investigator would make IM injection unsafe.

Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).

Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RSV/hMPV_V low dose vaccine

    Biological/Vaccine

    RSV/hMPV\_V low dose vaccine administered intramuscularly.

  • RSV/hMPV_V medium dose vaccine

    Biological/Vaccine

    RSV/hMPV\_V medium dose vaccine administered intramuscularly.

  • RSV/hMPV_V high dose vaccine

    Biological/Vaccine

    RSV/hMPV\_V high dose vaccine administered intramuscularly.

  • RSV/hMPV_W low dose vaccine

    Biological/Vaccine

    RSV/hMPV\_W low dose vaccine administered intramuscularly.

  • RSV/hMPV_W medium dose vaccine

    Biological/Vaccine

    RSV/hMPV\_W medium dose vaccine administered intramuscularly.

  • RSV/hMPV_W high dose vaccine

    Biological/Vaccine

    RSV/hMPV\_W high dose vaccine administered intramuscularly.

  • RSV/hMPV_X low dose vaccine

    Biological/Vaccine

    RSV/hMPV\_X low dose vaccine administered intramuscularly.

  • RSV/hMPV_X medium dose vaccine

    Biological/Vaccine

    RSV/hMPV\_X medium dose vaccine administered intramuscularly.

  • RSV/hMPV_X high dose vaccine

    Biological/Vaccine

    RSV/hMPV\_X high dose vaccine administered intramuscularly.

  • hMPV_Y low dose vaccine

    Biological/Vaccine

    hMPV\_Y low dose vaccine administered intramuscularly.

  • hMPV_Y medium dose vaccine

    Biological/Vaccine

    hMPV\_Y medium dose vaccine administered intramuscularly.

  • hMPV_Y high dose vaccine

    Biological/Vaccine

    hMPV\_Y high dose vaccine administered intramuscularly.

  • hMPV_Z low dose vaccine

    Biological/Vaccine

    hMPV\_Z low dose vaccine administered intramuscularly.

  • hMPV_Z medium dose vaccine

    Biological/Vaccine

    hMPV\_Z medium dose vaccine administered intramuscularly.

  • hMPV_Z high dose vaccine

    Biological/Vaccine

    hMPV\_Z high dose vaccine administered intramuscularly.

  • Control vaccine

    Biological/Vaccine

    Control vaccine administered intramuscularly.

  • Placebo

    Combination product

    Placebo administered intramuscularly.

Treatment groups

1,456 Participants
are divided into 26 treatment groups

26

Treatment groups

See each treatment group below.

Group A: RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) GroupExperimental treatment 1 intervention
Group B: RSV/hMPV_X_medium dose_Ph1_YA GroupExperimental treatment 1 intervention
Group C: RSV/hMPV_X_high dose_Ph1_YA GroupExperimental treatment 1 intervention
Group D: hMPV_Y_high dose_Ph1_YA GroupExperimental treatment 1 intervention
Group E: hMPV_Z_low dose_Ph1_YA GroupExperimental treatment 1 intervention
Group F: hMPV_Z_medium dose_Ph1_YA GroupExperimental treatment 1 intervention
Group G: hMPV_Z_high dose_Ph1_YA GroupExperimental treatment 1 intervention
Group H: Control Vaccine_Ph1_YA GroupActive comparator 1 intervention
Group I: Placebo_Ph1_YA GroupPlacebo comparator 1 intervention
Group J: RSV/hMPV_V_low dose_Ph1 and Ph2_Older Adults (OA) GroupExperimental treatment 1 intervention
Group K: RSV/hMPV_V_medium dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group L: RSV/hMPV_V_high dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group M: RSV/hMPV_W_low dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group N: RSV/hMPV_W_medium dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group O: RSV/hMPV_W_high dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group P: RSV/hMPV_X_low dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group Q: RSV/hMPV_X_medium dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group R: RSV/hMPV_X_high dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group S: hMPV_Y_low dose_Ph1_OA GroupExperimental treatment 1 intervention
Group T: hMPV_Y_medium dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group U: hMPV_Y_high dose_Ph1 and Ph2_OA GroupExperimental treatment 1 intervention
Group V: hMPV_Z_low dose_Ph1_OA GroupExperimental treatment 1 intervention
Group W: hMPV_Z_medium dose_Ph1_OA GroupExperimental treatment 1 intervention
Group X: hMPV_Z_high dose_Ph1_OA GroupExperimental treatment 1 intervention
Group Y: Control Vaccine_Ph1 and Ph2_OA GroupActive comparator 1 intervention
Group Z: Placebo_Ph1 and Ph2_OA GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Reporting Solicited Administration Site Events

Solicited administration site events include pain, redness (erythema) and swelling at administration site.

Time frame
Day 1 to Day 7
2

Number of Participants Reporting Solicited Systemic Events

Solicited systemic events include fever \[defined as oral or axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F\], headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).

Time frame
Day 1 to Day 7
3

Number of Participants Reporting Unsolicited Adverse Events (AEs)

An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.

Time frame
Day 1 to Day 30
4

Number of Participants Reporting Medically Attended Adverse Events (MAAEs)

MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.

Time frame
Day 1 to Month 12

Secondary outcomes

1

Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value

Time frame
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
2

Geometric mean titers (GMTs) of hMPV neutralization titers

Time frame
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
3

Mean geometric increase (MGI) of hMPV neutralization titers

Time frame
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
4

Seroresponse rate (SRR) against hMPV

SRR is defined as the number of participants having \>=4-fold increase post-vaccination in neutralization titers against hMPV.

Time frame
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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