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Nasal vaccine could shield newborns from whooping cough

NCT ID NCT01188512

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new whooping cough vaccine given as a nasal spray. 48 healthy adult men received either the vaccine or a placebo to check safety and immune response. The goal is to develop a single-dose vaccine that can protect infants from birth, before they get their regular shots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Start date

Aug 2010

Finished

Jan 2012

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 31 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subject will be included in the study if he meets all the following criteria: * Healthy male born between 1979 and 1991 who has not experienced clinical pertussis (lab. Verified) during the past 10 years and who has not been vaccinated with any pertussis vaccine. * Informed consent form signed by the subject. * Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures (e.g. able to read and write Swedish). Exclusion Criteria: If any of the following criteria are met, the subject must not be included in the study: * Individuals with pertussis toxin serum IgG antibodies ≥20 units/mL. * Blood pressure after resting ≥ 150/90 mmHg. * Heart rate after resting ≥80 bpm. * Respiratory rate after resting ≥ 20/minute. * Unwillingness to refrain from the use of nicotine products from screening through day 28. * Use of narcotic drugs/alcohol and/or a history of previous use of drug/alcohol abuse whitin the past 2 years prior to screening * The subject has donated blood or suffered from blood loss of at least 450 ml (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening. * Receipt of immunoglobulin, blood derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days prior to day 0. * Use of corticosteroids in the respiratory tract(e.g. nasal steroids, inhaled steroids) whitin 30 days prior to day 0. * Use of herbal medications or dietary supplements within 7 days prior to day 0 at the discretion of the investigator. Unwillingness to refrain from herbal medications or dietary supplements within 30 days after day 0 at the discretion of the investigator. * Receipt of a vaccine within the last 30 days prior to day 0 or planned vaccination within the next 30 days after day 0. * Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine. * Known hypersensitivity to any component of the study vaccine. * Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0. * Inability to adhere to the protocol, including plans to move from the area. * Family history of congenital or hereditary immunodeficiency (first degree). * Infection with HIV, hepatitis B or C. * Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. * Clinically significant abnormal laboratory values at the discretion of the investigator. * Person in frequent contact with children less than 1 year of age (father, childcare worker, nurse, etc…) or residence in the same household as persons with known immunodeficiency.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Karolinska University Hospital

    Solna, 171 76, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.